Method of lubricating body cavities



Sept- 29, 4 A. CARLS'ON, JR.. ETAL 3,150,652

METHOD OF LUBRICATING BODY CAVITIES File d Dec. 7. 1 961 INVENTOfiQ ARTHUR (mzLsou I! lZunoLpu Qtrlur-u ATTORNEY: v

United States Patent F METHOD OF LUBRICATING BODY CAVITIES Arthur Carlson, .lr., Humboldt, Kans, and Rudolph Seiden, Kansas City, Mo., assignors to Haver- Loekhart Laboratories, Kansas City, Mo., a corporation of California Filed Dec. 7, 1961, Ser. No. 157,725 5 Claims. (Cl. 128-260) This invention relates to medicament packages, and the method of using such medicament packages in relieving dystocia or difficult births and the like which usually result from malpresentation of the fetus and dryness of the birth or like canal.

This application is a continuation in part of our pending application on Medicament Package and Method of Using Same, Serial No. 18,962, filed March 31, 1960, now abandoned.

Difficult births in farm animals, such as equines, ruminants and swine, are relatively common. Such births or dystocia usually are due to malpresentation of the fetus and dryness of the birth canal. The malpresentation may be due to the head and a foreleg of the fetus being together in the restricted area or cervix which is over the pelvis in such animals or other deviations or retentions providing presentations that differ from normal. These conditions create a danger that the fetus may be stillborn, that an infectious condition such as metritis or cerw'citis may occur or germs and infection may be introduced into the organs of the animal by insertions of devices or members in elforts to aid the birth or effect passage of obstructing elements from such canals. Attempts have been made to apply lubricant to birth canals of animals in dystocia cases by pumping or otherwise introducing such lubricant, but such methods have been ineificient and unsatisfactory.

The principal objects of the present invention are to provide a medicament package including a flexible envelope of impervious material and containing medicaments such as lubricants, anti-infectives, antibiotics, antiseptics or anesthetics or combinations thereof wherein the envelope material is inert or unaifected by the solution contained therein; to provide sucha medicament package containing a suitable lubricant and/ or anti-infective, antiseptic or the like for introduction into body cavities; to provide a plastic package for use in conveying medicaments and/or lubricants into a body cavity such as the vagina, cervix, uterus, rectum, mouth or throat wherein the medicament and/or lubricant is liberated manually as by manualrupturing of the package; to provide a method of introducing and applying suitable solutions of lubricant and anti-infectives or antiseptic at desired locations in animal canals for reducing dystocia and infectious conditions therein; to provide a medicament package of suitable solutions wherein the envelope or container is rupturable by squeezing to discharge the contained solutions over surrounding surfaces; to provide such a package that causes no ill effects if dropped into the gravid horn of the animals uterus as it is removed or discharged with the placenta; to provide a rupturable medicament package and method of using same wherein the package is of a size and property of being grasped in a users hand and inserted therewith into the uterus of an animal in the process of giving birth and squeezing by said hand releases and disperses the solution onto surrounding surfaces; and to provide a medicament package and method of using same that is eflicient in maintaining the solution contained therein in contamination-free condition and is efficient in application to surfaces of animal canals.

Other objects and advantages of this invention will become apparent from the following description taken in 3,156,662 Patented Sept. 29,, 1964 connection with the accompanying drawings wherein are set forth by way of illustration and example certain embodiments of this invention.

FIG. 1 is a perspective view of a medicament packet embodying the features of the present invention, with portions broken away to illustrate the structure thereof.

FIG. 2 is a perspective view showing the medicament packet folded and grasped in a hand for insertion to a point of application.

FIG. 3 is a diagrammatic View illustrating a method of insertion of the packet to a position for rupturing and releasing of the contents thereof.

Referring more in detail to the drawings:

According to the invention, the package 1 consists of a quantity of a solution 2 of suitable anti-infectives, antibiotics, antiseptics, anesthetics or lubricants or combinations thereof contained in a sealed envelope or container 3 and for use or treatment by introduction into a body cavity such as vagina, cervix, uterus, rectum and the like wherein the solution is liberated manually as by rupturing the envelope manually.

The solution 2 may be any suitable medicament material for application to animal canals, and particularly a lubricant material in liquid or gel or ointment form such as lubricants having a vegetable base, for example, locust bean gum, arabic gum, tragacanth and the like, or modified fatty alcohol sulfates, for example, sodium lauryl sulfate or ammonium lauryl sulfate or the sodium and potassium salts of saturated or unsaturated fatty acids, and/ or glycerine together with a suitable anti-infective or antiseptic, as for example, quaternary ammonium compounds, metal compounds such as mercury bichloride aluminum acetate, or phenol derivatives such as phenyl mercuric nitrate, p-chloro-m-cresol, or a halogenated phenol derivative, such as hexachlorophene, and/ or other bactericides or bacteriostat or other suitable medicament, said lubricant and anti-infective or antiseptic or other medicament preferably being soluble in water. The solution also preferably includes sufficient water and/ or thickening agents to form a liquid of suitable viscosity or a suitable suspension, emulsion or gel.

The envelope or bag 3 is preferably flexible and formed of an organic polymeric material that is unaffected by the solution contained therein and that is impervious and capable of being sealed as by heat sealing or suitable adhesive. It is preferable that the envelope be formed from flexible films of thermoplastic synthetic resins such as polypropylene, polyethylene, vinyl chloride polymer or laminates thereof with other suitable films whereby the lm of the envelope has suitable strength to contain the solution under rough handling during shipping, handling and the like, and yet be such that with a solution therein pressure applied to the exterior as by squeezing in a persons hand will cause the film to rupture and release the solution. A suitable package for use in relieving dystocia in animals such as ruminants or cows is preferably formed from a film 4 of polypropylene of suitable thickness as, for example, up to 4 mils, or a polyethylene, 2 mils thickness, laminated to a backing of Cellophane film 5 to provide added strength. The packets for use in aiding births in cows and the like include an envelope of such film, preferably cut to a suitable size to form the packet or bag approximately 4 /2 inches wide and 9 inches long, with the polyethylene lamination on the interior. The envelope is preferably heat sealed as at 6 alnog the marginal edges, leaving one end edge open for filling with the solution and, after filling, the marginal edges at the open end are preferably heat sealed as at 7. This forms a dispensing unit adapted to contain substantially six ounces of the solution by weight.

The quantity of the solution and the size of the package may vary for different treatments or different animals, and it is preferred that the solution of lubricant and/ or anti-infective or antiseptic be such that it will mix with the natural fluids or water in the animal canal to provide further dilution and wetting of the surfaces thereof. A suitable solution may be in the nature of locust bean gum 2 percent, glycerine 6 percent, pchlor-m-cresol .2 percent and distilled water 90 percent, the percentages being by weight. Another suitable solution may consist of a modified fatty alcohol sulfate 50 percent and water 50 percent. Another example of a suitable solution is modified fatty alcohol sulfates 50 percent, glycerine 2 /2 percent, a thickener such as a trace of gum tragacanth, sodium chloride trace, hexachlorophene .1 percent, and water approximately 4-7 percent, all of said percentages being by weight. Another suitable example is sodium lauryl sulfate 3 ounces, glycerine .15 ounces, hexachlorophene. .006 ounces, and Water approximately 2.85 ounces. The ingredients of the solution are thoroughly mixed to form a viscous free flowing liquid and, with the bag or envelope having three edges suitably closed and secured at the margins by suitable adhesives or by heat sealing, the other or open end has the edges spread and, for example, a piston type filler used to insert the desired quantity of the solution into the interior of the bag or envelope. The envelope or bag is then removed from the filler, and the open end closed by flattening the end portions and securing the margins thereof together by heat sealing or suitable adhesive to form the sealed packet 1, which is air-tight to maintain the solution 2 in a contaminationfree condition.

When an animal is in the process of a diflicult birth as, for example, when the fetus 8 is malpresented, as illustrated in FIG. 3, wherein the head 9 and one foreleg 10 of the fetus 8 are together in the restricted area or cervix lll over the pelvis 12 of the animal, the surface of the birth canal 13 or vagina rapidly becomes dry, increasing the difficulty in the birth. A veterinarian or other person, in using the packet 1, folds same intermediate its length, as at 15, and grasps said folded packet in a hand 16. Said person then inserts his hand preferably with the fingers upwardly into the vulva 17 of the animal and moves same inwardly preferably to a position as at 18 in the cervix of the animal, and then by squeezing the packet l to apply pressure thereon the film forming the envelope is ruptured, and due to the squeezing pressure causing the rupture the contents or solution in the envelope is widely dispersed as it is released from the ruptured envelope onto the surrounding surfaces of the fetus and uterus. In some instances to facilitate directing the principal distribution of the solution on particular areas, the envelope may be punctured before insertion. While usually one packet of the lubricant and anti-infective or antiseptic is suflicient, if desired, the hand may be removed and another packet inserted, and the process repeated to provide additional lubricant in the uterus of the animal. If the canal is too small for insertion by hand, the envelope containing the solution may be inserted and pressed for breaking by an instrument to provide a quick rupture that will discharge the solution under pressure to distribute same over a wide area of the surrounding surfaces. It is preferred that the veterinarian or other person aiding in the birth massage the surfaces of the cervix to aid in spraeding the solution thereover, and also to aid in the supply of the natural fluids or water for suitable lubrication and enlargement at the cervix whereby the fetus may be drawn therethrough. If, in the breaking of the envelope and the release thereof during the massaging operation said envelope should move into the gravid horn 19 of the uterus, it Will be discharged or removed with the placenta. If desired, an additional packet may be broken in the uterus to aid in the removal of the placenta or afterbirth, whereby both the lubricant and the antiseptic and/or other medicament will provide a treatment to reduce possibility of infectious conditions, both from conditions present in the animal or from germs and the like that might be introduced during the assisting of the birth.

The packaging material or film of the envelope of the present invention is necessarily inert to the solution contained therein, and also to the natural body fluids in the animal canal, as said envelope must not combine with the solution or fluids to form any undesirable reaction. The packaging material or film is employed in the form of a resilient scalable sheet or film which completely encloses the solution, and it is desirable that said film be strong enough to be readily transported and handled without rupture or breakage and that it be unaffected by the solution in storage over a period of time and harmless to the touch. It must be such that it will withstand drop tests of the packet but be rupturable when pressure is applied by squeezing with the hand whereby the solution is placed under pressure and then discharged with sufficient velocity to distribute same over a substantial area of the animal canal.

It is to be understood that while We have illustrated and described certain forms of our invention, it is not to be limited to the specific forms or arrangement of parts herein described and shown except insofar as such limitations are included in the claims.

What we claim and desire to secure by Letters Patent is:

1. In applying medicaments into body cavities, the steps of bodily introducing into and entirely within a body cavity, a liquid solution of lubricant and an anti-infective enclosed in a completely sealed flexible bag consisting of a thermoplastic film unaffected by the liquid solution and rupturable by squeezing, grasping said bag in enclosing relation to a substantial portion including opposed portions thereof leaving another portion exposed, and squeezing said bag to apply external pressure to said exposed portions and the liquid solution in said bag whereby said pressure effects an internal force at said exposed portion and ruptures said bag to expel and disperse said liquid solution onto surrounding inner surfaces in said body cavity.

2. In the assisting of difficult births in animals, the steps of bodily introducing into and entirely within the uterus of an animal in process of giving birth, a liquid solution of lubricant and an antiseptic enclosed in a completely sealed flexible bag consisting of a thermoplastic substance of the group consisting of polypropylene, polyethylene and vinyl chloride polymer treated to be unaffected by the liquid solution and rupturable by squeezing, and squeezing said bag to apply pressure to a substantial portion thereof and effect rupture of said bag whereby the liquid solution is dispersed onto surrounding inner surfaces of the uterus.

3. In the assisting of diflicult births in animals, the steps of bodily introducing into and entirely within the uterus of an animal in process of giving birth, a liquid solution of lubricant and an antiseptic enclosed in a completely sealed flexible bag consisting of a thermoplastic substance of the group consisting of polypropylene, polyethylene and vinyl chloride polymer treated to be unaffected with the liquid solution and rupturable by squeezing, squeezing said bag to apply pressure to a substantial portion thereof and effect rupture of said bag whereby the liquid solution is dispersed onto surrounding inner surfaces of the uterus, and massaging said surrounding inner surfaces to spread said liquid solution thereon.

4. In the assisting of difficult births in animals, the steps of bodily introducing into and entirely within the uterus of an animal in process of giving birth, a liquid solution of modified fatty alcohol sulfate and an antiseptic enclosed in a completely sealed flexible bag consisting of a thermoplastic substance of the group consisting of polypropylene, polyethylene and vinyl chloride polymer laminated with Cellophane and unaffected by the liquid solution and rupturable by squeezing, squeezing said bag to apply pressure to a substantial portion thereof and effect rupture of said bag whereby the liquid solution is dispersed onto surrounding inner surfaces of the uterus, and massaging said surrounding inner surfaces to spread said liquid solution thereon.

5. In the assisting of difficult births in animals, the steps of bodily and entirely introducing to within the uterus of an animal in process of giving birth, a liquid solution of lubricant and an antiseptic enclosed in a completely sealed elongate flexible bag consisting of a thermoplastic film that is impervious and unaffected by the liquid solution and is rupturable from internal pressure of the liquid solution effected by squeezing of said bag, said bag having a width in the nature of one-half the length thereof, folding said bag to form a transverse fold and position end portions in relative overlying relation, grasping the overlying portions of said bag and leaving the fold thereof exposed, and then with said bag of liquid solution in the uterus squeezing said overlying portions to apply external pressure to a substantial portion of the bag and the liquid solution therein whereby said pressure effects an internal pressure and rupture of said bag adjacent said fold to expel and disperse the liquid solution onto surrounding inner surfaces of the uterus.

References Cited in the file of this patent UNITED STATES PATENTS 1,978,217 Muckerjee Oct. 23, 1934 1,981,123 Roche Nov. 20, 1934 2,512,115 Senff June 20, 1950 2,562,402 Winsten July 31, 1951 2,720,881 Jones Oct. 18, 1955 2,742,396 Sperandio Apr. 17, 1956 2,804,421 Stirn et a1 Aug. 27, 1957 2,864,368 Senger Dec. 16, 1958 2,874,087 Obladen Feb. 17, 1959 FOREIGN PATENTS 228,579 Germany Nov. 12, 1910 

1. IN APPLYING MEDICAMENTS INTO BODY CAVITIES, THE STEPS OF BODILY INTRODUCING INTO AND ENTIRELY WITHIN A BODY CAVITY, A LIQUID SOLUTION OF LUBRICANT AND ANTI-INFECTIVE ENCLOSED IN A COMPLETELY SEALED FLEXIBLE BAG CONSISTING OF A THERMOPLASTIC FILM UNAFFECTED BY THE LIQUID SOLUTION AND RUPTURABLE BY SQUEEZING, GRASPING SAID BAG IN ENCLOSING RELATION TO A SUBSTANTIAL PORTION INCLUDING OPPOSED PORTIONS THEREOF LEAVING ANOTHER PORTION EXPOSED, AND SQUEEZING SAID BAG TO APPLY EXTERNAL PRESSURE TO SAID EXPOSED PORTIONS AND THE LIQUID SOLUTION IN SAID BAG WHEREBY SAID PRESSURE EFFECTS AN INTERNAL FORCE AT SAID EXPOSED PORTION AND RUPTURES SAID BAG TO EXPEL AND DISPERSE SAID LIQUID SOLUTION ONTO SURROUNDING INNER SURFACES IN SAID BODY CAVITY. 